510(k) Report

FDA applicant

Hichem Diagnostics

Brea, CA41 decisions1988–19980 recalls

FDA records 41 decisions for Hichem Diagnostics (Brea, CA) from 1988 to 1998: 41 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and JIX (Calibrator, Multi-Analyte Mixture). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Hichem Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hichem Diagnostics since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hichem Diagnostics by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JJYMulti-Analyte Controls, All Kinds (Assayed)7decisions
  • JIXCalibrator, Multi-Analyte Mixture4decisions
  • CGZElectrode, Ion-Specific, Chloride3decisions
  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)2decisions
  • CJYAzo Dye, Calcium2decisions
  • CHHEnzymatic Esterase--Oxidase, Cholesterol2decisions

Also: JJE (2), JFL (2), JGS (2), CDS (1), JQB (1), CGX (1).

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K925611HI Chem Electrolyte Reference ReagentHichem Diagnostics · 19931cites it

What has FDA decided for it lately?

  • K981794Hichem Calcium Reagent KitHichem Diagnostics · 1998
  • K963383Hichem Alp/Amp Reagent KitHichem Diagnostics · 1996
  • K953862Hichem Isekci Solution Kit 70010Hichem Diagnostics · 1995
  • K953860Hichem Ise Diluent Kit 70008Hichem Diagnostics · 1995
  • K953863Hichem Ise Standards Kit 70011Hichem Diagnostics · 1995
  • K953861Hichem Ise Intdernal Reference Kit 70009Hichem Diagnostics · 1995
  • K951751Hichem Ast Reagent KitHichem Diagnostics · 1995
  • K946192Hichem Y-GT Reagent KitHichem Diagnostics · 1995

All 41 as Hichem Diagnostics →